Neuropsychiatric Disease and Treatment

MIRA Pharmaceuticals Announces Paradigm-Shift in Cognitive Enhancement with MIRA1a

Retrieved on: 
Tuesday, November 21, 2023

BALTIMORE, Nov. 21, 2023 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company, today revealed groundbreaking insights into the cognitively enhancing effects of MIRA1a in normal mice during a presentation at the University of Louisville's Christine Lee Brown Envirome Institute's Grand Rounds from Dr. Adam Kaplin, MD, Ph.D., President and Chief Scientific Officer of MIRA Pharmaceuticals and Adjunct Faculty member at the Johns Hopkins School of Medicine.

Key Points: 
  • Unprecedented Cognitive Boost: MIRA1a demonstrated a doubling of the performance of normal adult mice in learning and memory tests, showcasing MIRA1a's potential to elevate cognitive abilities beyond normal thresholds.
  • "The revelation of MIRA1a's dramatic cognitive enhancement potential acutely after even a single dose marks a seismic shift in neuropsychiatric research," said Dr. Kaplin, MD, Ph.D., President and Chief Scientific Officer of MIRA.
  • "This discovery positions MIRA Pharmaceuticals at the forefront of transformative developments in psychotropic drug innovation."
  • Erez Aminov, Chief Executive Officer of MIRA, added: "At MIRA Pharmaceuticals, we are committed to seizing industry-defining opportunities.

INBRAIN Neuroelectronics Announces FDA Breakthrough Device Designation for Its Graphene-Based Intelligent Network Modulation Platform

Retrieved on: 
Tuesday, September 19, 2023

, a health-tech company dedicated to developing the world’s first intelligent graphene-neural platform, today announced that its Intelligent Network Modulation System has been granted Breakthrough Device Designation (BDD) from the U.S. Food & Drug Administration (FDA) as an adjunctive therapy for treating Parkinson’s disease.

Key Points: 
  • , a health-tech company dedicated to developing the world’s first intelligent graphene-neural platform, today announced that its Intelligent Network Modulation System has been granted Breakthrough Device Designation (BDD) from the U.S. Food & Drug Administration (FDA) as an adjunctive therapy for treating Parkinson’s disease.
  • The thinnest material known, yet stronger than steel, graphene’s unique combination of electrical and mechanical properties makes it ideal for neurotechnology innovation.
  • “Breakthrough device designation from the FDA signifies the potential of the INBRAIN neural platform to further improve the lives of patients with Parkinson’s disease,” said INBRAIN Neuroelectronics Clinical Affairs Head Dan Gnansia.
  • “INBRAIN’s new generation of ultrathin graphene-based high resolution interfaces and associated network platform may vastly improve the precision, efficiency and efficacy of DBS and closed-loop or adaptive modulation.

Motif Neurotech Conducts First-in-human Brain Stimulation With Millimeter-sized Implantable Device for Treatment-resistant Depression

Retrieved on: 
Monday, September 18, 2023

In intraoperative studies, the team showed that their miniature implants could safely and effectively stimulate the human brain without contacting the brain surface.

Key Points: 
  • In intraoperative studies, the team showed that their miniature implants could safely and effectively stimulate the human brain without contacting the brain surface.
  • They further showed their implants provided safe and effective brain stimulation in large animal studies lasting over 30 days.
  • Motif is developing a miniature brain pacemaker that is designed to precisely stimulate the brain to restore healthy circuit activity to treat mental health disorders.
  • “This tiny device, which cannot be seen once implanted, provides at-home stimulation that engages brain networks known to treat depression.

Arialys Therapeutics Launches to Lead the Development of New Precision Medicines for Autoimmune Neuropsychiatric Diseases

Retrieved on: 
Tuesday, September 12, 2023

Arialys Therapeutics , a biotechnology company pioneering new therapeutics for autoimmune neuropsychiatry, today announced the close of $58 million in seed financing.

Key Points: 
  • Arialys Therapeutics , a biotechnology company pioneering new therapeutics for autoimmune neuropsychiatry, today announced the close of $58 million in seed financing.
  • The proceeds of the financing will be used to advance new precision medicines that specifically block pathogenic autoantibodies in the central nervous system (CNS) and meaningfully expand the treatment possibilities for neuropsychiatric diseases driven by autoimmunity.
  • “Recent scientific discoveries have implicated abnormal autoimmune activity in a number of neuropsychiatric diseases, pointing us in a new direction to develop precision medicines for CNS disorders,” said Jay Lichter, PhD, President and CEO of Arialys and Managing Partner of Avalon BioVentures.
  • Arialys has received orphan drug designation from the U.S. Food and Drug Administration for ART5803 for the treatment of ANRE.

Beacon Biosignals Acquires Dreem, Launches At-home Sleep Monitoring Services for Clinical Trials

Retrieved on: 
Tuesday, July 11, 2023

Dreem, a market leader in developing clinically-validated sleep monitoring devices, is poised to markedly enhance Beacon's capabilities in data acquisition and clinical trial operations, creating substantial value for Beacon's biopharma partners.

Key Points: 
  • Dreem, a market leader in developing clinically-validated sleep monitoring devices, is poised to markedly enhance Beacon's capabilities in data acquisition and clinical trial operations, creating substantial value for Beacon's biopharma partners.
  • As part of this acquisition, Beacon Biosignals secured an undisclosed financing round with participation from its syndicate of Series A investors, led by General Catalyst.
  • At-home, longitudinal monitoring is positioned to progress the underlying science of sleep physiology beyond what is possible with limited assessments in an unnatural sleep lab setting.
  • Prominent sleep expert and Beacon Biosignals Scientific Advisory Board member, Dr. Andrew Krystal, MD, added, "Sleep plays a crucial role in neuropsychiatric diseases, and monitoring it in realistic, at-home settings is essential for understanding the full impact on patients.

Cyclerion Reports Corporate Update and Full Year 2022 Financial Results

Retrieved on: 
Wednesday, March 22, 2023

More recently, Cyclerion filed a request with the FDA for Orphan Drug Designation and manufactured drug product to support the Phase 2b study.

Key Points: 
  • More recently, Cyclerion filed a request with the FDA for Orphan Drug Designation and manufactured drug product to support the Phase 2b study.
  • Cash, cash equivalents, and restricted cash balance on December 31, 2022 was approximately $13.4 million, as compared to approximately $20.4 million on September 30, 2022.
  • Research and development expenses were approximately $31.5 million for the full year 2022, as compared to approximately $37.6 million for the full year 2021.
  • Net Loss: Net loss was approximately $44.1 million for the full year 2022, as compared to $51.6 million for the full year 2021.

Transcend Therapeutics, a mental health-focused biotechnology company, announces Series A funding round of $40 million led by Alpha Wave Global and Integrated Investment Partners

Retrieved on: 
Thursday, February 23, 2023

NEW YORK, Feb. 23, 2023 /PRNewswire/ -- Transcend Therapeutics, a biotechnology company that develops medicines to treat neuropsychiatric diseases, including post-traumatic stress disorder (PTSD), today announced that it closed its Series A funding round of $40 million. Led by Alpha Wave Global and Integrated Investment Partners, this funding round will enable Transcend to launch multiple clinical trials, including a phase II study, with its next-generation psychoactive compound. Transcend has raised nearly $42 million to date.

Key Points: 
  • Led by Alpha Wave Global and Integrated Investment Partners, this funding round will enable Transcend to launch multiple clinical trials, including a phase II study, with its next-generation psychoactive compound.
  • While various psychedelics have demonstrated promise for the treatment of PTSD, Transcend focuses on a psychoactive compound that may be more accessible for the tens of millions of patients in need.
  • Its lead compound, methylone (TSND-201), has short-acting and mild psychological effects, and thus likely requires less clinician time than other psychedelic compounds.
  • The Series A round was also supported by Global Founders Capital and Emerald Investment Managers, among others.

EuMentis Therapeutics Inc. Receives $3 Million Award from United States Department of Defense (DoD) to Advance its Novel NMDA Receptor Antagonist for Traumatic Brain Injury

Retrieved on: 
Wednesday, February 8, 2023

A key scientific focus of EuMentis is to advance novel fast-off NMDAR antagonists to block signaling of over-active glutamate receptors in order to restore glutamate balance across diseases and indications, including TBI.

Key Points: 
  • A key scientific focus of EuMentis is to advance novel fast-off NMDAR antagonists to block signaling of over-active glutamate receptors in order to restore glutamate balance across diseases and indications, including TBI.
  • Once the preclinical study is completed, EuMentis plans to advance the selected lead candidate into a Phase I clinical trial in 2024.
  • To date, EuMentis has received over $11 million in funding from private and government sources to support research and development of its broad pipeline of novel CNS-based therapeutics.
  • “Currently there are no approved therapeutics for traumatic brain injury, which impact hundreds of thousands of Americans annually and leads to significant disability and death.

atai Life Sciences Company GABA Therapeutics Announces Positive Final Results from Phase 1 Single and Multiple Ascending Dose Trial of GRX-917

Retrieved on: 
Monday, January 9, 2023

GRX-917 was well tolerated with sedation comparable to placebo noted over the entirety of the dose range explored.

Key Points: 
  • GRX-917 was well tolerated with sedation comparable to placebo noted over the entirety of the dose range explored.
  • Initiation of a GRX-917 efficacy study is anticipated in H1 2023 with results expected in 2024.
  • NEW YORK and BERLIN, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Today, atai Life Sciences N.V. (Nasdaq: ATAI) (“atai” or “the Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, and its subsidiary GABA Therapeutics, announced final positive results from a Phase 1 clinical trial of GRX-917 that were previously announced as preliminary results during atai’s R&D day.
  • The randomized, double-blind, placebo-controlled trial was designed to evaluate the safety, tolerability, and pharmacokinetic profile of single and multiple ascending doses of orally administered GRX-917.

PHASE II/III CLINICAL TRIAL OF SIMCERE'S 3CL-TARGETING ANTI-SARS-COV-2 DRUG CANDIDATE COMPLETE ALL PATIENTS ENROLLMENT

Retrieved on: 
Tuesday, December 20, 2022

Simcere will accelerate the analysis of clinical study results and actively prepare for New Drug Application (NDA), while speeding up the expansion of production capacity to meet urgent clinical needs.

Key Points: 
  • Simcere will accelerate the analysis of clinical study results and actively prepare for New Drug Application (NDA), while speeding up the expansion of production capacity to meet urgent clinical needs.
  • This is to fulfill the Group's corporate mission of "providing today's patients with medicines of the future".
  • The Study has established a total of 43 clinical research centers in 20 provinces, municipalities and autonomous regions in China.
  • XIANNUOXIN is a combination packaged drug of a small molecule anti- SARS-CoV-2 drug candidate and Ritonavir, this candidate is targeted 3CL protease which is essential for SARS-CoV-2 viral replication.